Patent No. US12262911 (titled "Methods And Systems For Treatment Of Acute Ischemic Stroke") was filed by Route 92 Medical Inc on Sep 3, 2020.
’911 is related to the field of medical devices, specifically those used for treating acute ischemic stroke. The background of the invention lies in the challenges associated with accessing and treating cerebral occlusions, where quick intervention is crucial. Existing methods, often involving transfemoral access, can be time-consuming and carry a risk of embolic complications due to the tortuous path through the aortic arch and carotid arteries. The invention aims to provide a faster and safer route to the cerebral vasculature.
The underlying idea behind ’911 is to simplify and expedite access to cerebral arteries by using a transcervical approach directly to the common carotid artery. This shorter, straighter path reduces the risk of embolic events and decreases the time required to reach the occlusion. The key insight is that direct access to the carotid artery, combined with specialized catheters and aspiration techniques, can significantly improve stroke treatment outcomes.
The claims of ’911 focus on a catheter system designed for navigating the cerebral vasculature. The system includes a catheter and an inner member (dilator) with a tapered distal portion. This tapered design creates a smooth transition in flexibility between the guidewire and the catheter, facilitating advancement through tortuous vessels, specifically beyond the petrous portion of the internal carotid artery. The claims emphasize the assembled system's flexibility and ability to reach distal locations in the cerebral vasculature.
In practice, the system works by first inserting a guidewire into the cerebral vessel. The catheter and inner member assembly are then advanced over the guidewire. The tapered inner member minimizes any 'step' or abrupt change in diameter at the catheter tip, allowing for smoother navigation through tight turns and past vessel bifurcations. Once the catheter is in position, the inner member can be removed, leaving the catheter in place for subsequent procedures like aspiration or thrombectomy.
This approach differentiates itself from prior methods by offering a more direct and less invasive route to the cerebral arteries. The shorter path and smoother transition at the catheter tip reduce the risk of vessel damage and embolic complications. By combining direct access with a carefully designed catheter system, ’911 aims to improve the speed and safety of stroke interventions, ultimately leading to better patient outcomes. The tapered dilator is a key element in achieving this improved navigation.
In the early 2010s when ’911 was filed, neurointerventional procedures commonly relied on transfemoral access to the cerebral arteries, at a time when device access challenges made B non-trivial. At a time when X was typically implemented using Y, embolic protection systems were not commonly used in interventional treatment of acute ischemic stroke due to the delicate anatomy and the need for rapid intervention.
The examiner approved the claims because the prior art, including Garrison, Chou, and Wilson, failed to disclose or suggest the unique combination of structure and function recited in the claims. Specifically, the examiner noted that the prior art did not teach a catheter system where, with the inner member in the advancement configuration and the guidewire extending distally, the inner member creates a smooth transition in flexibility between the guidewire and the catheter's distal end. This configuration allows the catheter and inner member to be advanced together over the guidewire to a petrous portion of an internal carotid artery. The examiner stated that this arrangement addresses the diameter mismatch in existing systems, which causes difficulty when navigating tortuous vessels.
This patent contains 25 claims, with claims 1 and 18 being independent. The independent claims are directed to a system of devices for performing a medical procedure in a cerebral vessel, comprising a catheter, an inner member, and a guidewire. The dependent claims generally elaborate on specific features, dimensions, materials, and configurations of the system components described in the independent claims.
Definitions of key terms used in the patent claims.
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